Cardiovascular · 510(k) · 2025
Loss of Pulse Detection
Fitbit. Cleared by FDA on 25 February 2025 under submission K242967, product code SDY (loss of pulse notification software). What FDA's record says, in FDA's words.
Device record · K242967
- Device. Loss of Pulse DetectionDEVICE
- Company. FitbitCOMPANY
- Decision. 25 February 2025, 510(k), substantially equivalent (traditional review); received 26 September 2024DECISION
- Panel. CardiovascularPANEL
- Product code. SDY, Loss Of Pulse Notification SoftwareCODE
- Regulation. 21 CFR 870.2790, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Loss of Pulse Detection is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse data to identify loss of pulse events and provide audio, visual, and haptic alerts to the user. If the user remains unresponsive to these alerts, Loss of Pulse Detection will attempt to prompt a call to emergency services through the user's connected compatible hardware, such as a smartphone or smartwatch. Loss of Pulse Detection is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every loss of pulse event and the absence of an alert is not intended to indicate that no such event has occurred; rather the Loss of Pulse Detection is intended to opportunistically surface an alert of possible loss of pulsatility when sufficient data are available for analysis. These data are only captured when the user is still. Loss of Pulse Detection is not intended to replace traditional methods of diagnosis, treatment, or monitoring. Loss of Pulse Detection has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with a high risk for sudden cardiac death such as those with coronary artery disease, cardiomyopathy and/or unexplained syncope/fainting.
The product code's definition, from FDA's classification record. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SDY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SDY, in Cardiovascular, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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